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Quality system
QA
QC
 

Lixin Pharmaceutical Company Limited has established a complete quality management system, delivered by the two executive organs QA and QC.

QC with professional analysts is responsible for the supervision of the quality of the products and research, and also responsible for perform inspection analysis, method verification and stability test for registered items all over the world.

Independent QA is focus on establish strict and sound quality management system, to ensure all of process of manufacture are finished in accordance with GMP. 

Until now , four major products of Lixin have met cGMP from the first certification in December 2005.  Meanwhile, some our products have applied FDA and European COS certificates.

Numbers

Time

Certifications

1

2005.12.

Hydrochlorothiazides, Dacarbazine have passed cGMP inspection.

2

2006.02.

Obtained the certification of cGMP(No:苏H0393)

3

2007.12.

DMF documents of Hydrochlorothiazide have been submitted to FDA.

3

2008.06.

Idebenone  have passed cGMP inspection.

4

2008.07.

Obtained the certification of cGMP(No:苏J0630)

5

2009.01.

cGMP certification of Indapamide  have been submitted

6

2009.01.

European  COS certification of Dacarbazine have been submitted

 
Scope of Inspection:Bulk Drugs[(Hydrochlorothiazide),(Antineoplastic Drugs:Dacarbazine)]
Scope of Inspection:Bulk Drug(Idebenone)
 
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